Does the US Food and Drug Administration (FDA) pull up Indian drug makers the most? Not really. Despite the recent instances of top Indian drug makers, including Ranbaxy Laboratories Ltd, Wockhardt Ltd, Lupin and Aurobindo Pharma Ltd, being bombarded with import alerts or warned about lax manufacturing practices by the FDA, only 47 drug manufacturing facilities or 9% of total units approved by the American regulator has been banned from exporting products (be it drugs, food products or medical devices) to the US market till date.
China has over 960 FDA-approved manufacturing sites, the highest number outside the US, and has around 8% of these sites under an import ban by the FDA, not very different from India in terms of incidence of adverse FDA action. However, if you look at countries like Mexico, the UK and Canada, the number of factories under an import alert as a percentage of total US registered sites is much higher that in India or China.
Remember that India has 526 manufacturing facilities approved by the American regulator, the second-highest number outside of US, and accounts for nearly 40% of the generic drugs sold in the that country.
While 74% of Mexican drug making sites registered with FDA are under a ban, around 30% of Canadian and British manufacturing facilities that are approved by the FDA to supply medicines have been issued an import alert.
FDA’s spokesperson in India, Christopher C Kelly, told FE that while the regulator is “confident that many (Indian) companies understand and have implemented good manufacturing practices (GMP), we (FDA) also remain vigilant to take appropriate action if or when lapses, occur”.
He added: “India’s success in providing a significant share of our generic products used in America and the growing percentage of their exports to the US are ample evidence of the pharmaceutical sector’s ability to meet US standards and regulations.”
India, which is second-largest drug exporter to the US, according to the FDA, exported $4.23 billion or 30% of total exports to the US market in 2012-13. Out of the country’s total pharmaceutical exports of $14.6 billion, India exports 19% to Europe, followed by 17% to Africa, 7% to West Asia and 5% to the CIS countries.
Analysts concede that although the FDA’s meticulousness and stringency of parameters both in terms of the quality of finished